Clinical trial
Valsartan Plus Hydrochlorothiazide in Patients With Hypertension and Cardiovascular Risk Factors
Name
CVAH631BCO02
Description
A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2 hypertension and cardiovascular risk factors.
Trial arms
Trial start
2004-02-01
Estimated PCD
2004-12-01
Trial end
2004-12-01
Status
Completed
Phase
Early phase I
Treatment
VALSARTAN+HYDROCHLOROTHIAZIDE
Size
76
Primary endpoint
Change from baseline systolic blood pressure at 8 weeks
Eligibility criteria
Inclusion Criteria:
* - Patients who give consent
* Men and women 18 to 80 years of age
* Patients with hypertension (systolic \>159 mm, diastolic \>100 mm)
* Patients meeting laboratory criteria
Exclusion Criteria:
* - Pregnant women
* Women not using approved contraception methods
* Secondary hypertension
Other protocol-defined exclusion criteria may apply.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 76, 'type': 'ACTUAL'}}
Updated at
2023-10-12
1 organization
1 product
1 indication
Organization
NovartisIndication
Hypertension